Gilphex

Product NDC: 58552-336
11-digit product format: 585520336
Labeler code: 58552
Product ID: 58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Gil Pharmaceutical Corp.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-05
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 390; 10 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Gilphex
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	390 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2603663	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e7c8fb97-02cf-4df6-b477-9ff69d6b675d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-336-01	Gilphex	100 in 1 BOTTLE	TABLET	100		5
58552-336-02	Gilphex	2 in 1 BLISTER PACK	TABLET	2		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-336-01	EA - Each	58552-336	8ae47051-d076-4783-a98d-35f5b573910e	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-336	GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.]	4	Current NDC, Legacy NDC, 2 package rows	20241027_e7c8fb97-02cf-4df6-b477-9ff69d6b675d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 83 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012
Desgen Pediatric	DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	12425c1b-8bdc-446b-83dd-95e05a4d9b8c	2025-12-04	Warnings	Exact identifier application number: M012
Presgen B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5befa829-32bd-4978-8a0e-1d6513ff37a4	2025-12-03	Warnings	Exact identifier application number: M012
TUSSLIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kramer Novis	987e19a5-032f-44e9-b4c7-8a764d502695	2025-12-03	Warnings	Exact identifier application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	450e8974-8ff8-4b82-e063-6394a90a9366	2025-12-03	Warnings	Exact identifier application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store Products, Inc.	4510223f-1c88-2796-e063-6394a90a18ac	2025-12-03	Warnings	Exact identifier application number: M012
Carolina Crud Crusher	DEXTROMETHORPHAN HBR, GUAIFENESIN	Weeks & Leo Co., Inc.	0b606683-7d68-cca5-e063-6394a90a6f58	2025-12-03	Warnings	Exact identifier application number: M012
Capmist DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Capital Pharmaceutical, LLC	63733ac3-859e-4a8e-8717-d852bd303408	2025-12-03	Warnings	Exact identifier application number: M012
ALA-HIST IR	DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	0d203b5c-8b10-428b-8703-17be6b4ce6eb	2025-12-03	Warnings	Exact identifier application number: M012
ALAHIST DM	DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	fdaa062d-110e-798d-e053-6394a90a755c	2025-12-03	Warnings	Exact identifier application number: M012
Alahist D	PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	a1b8533a-ef8b-57cc-e053-2995a90a5d9e	2025-12-03	Warnings	Exact identifier application number: M012
Alahist PE	DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	ada2d582-5813-2029-e053-2a95a90ae567	2025-12-03	Warnings	Exact identifier application number: M012
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	L.N.K. International, Inc.	9f2daffc-1904-4d64-9f84-689c88601e06	2025-12-03	Warnings	Exact identifier application number: M012
Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	d291faa9-894e-421c-8115-8a8c2a937172	2025-12-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2603663	guaiFENesin 390 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	5
2603663	guaifenesin 390 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-336-01	58552033601	100 TABLET in 1 BOTTLE (58552-336-01)	100 tablet	2022-05-05	0000-00-00	No	No	Current
58552-336-02	58552033602	2 TABLET in 1 BLISTER PACK (58552-336-02)	2 tablet	2022-05-05	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gilphex	Gil Pharmaceutical Corp. \| Syntho Pharmaceuticals, Inc.	2025-10-09	HUMAN OTC DRUG LABEL	5